Phase 2 N=95 Randomized Prevention

Smoking, Sex Hormones, and Pregnancy

Nicotine Dependence · Contraception

Bottom Line

View on ClinicalTrials.gov: NCT01811225 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Change in Smoking Urges — 5.0; 5.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Low-dose Progesterone (Drug); High-dose Progesterone (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Minnesota
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Smoking Urges	5.0; 5.5	—
SECONDARY Change in Positive and Negative Affect Scale Following Overnight Abstinence	26.21; 24.09; 17.01; 15.41	—
SECONDARY Change in Cohen Perceived Stress Scale	14; 15	—

Summary

The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

Eligibility Criteria

Inclusion Criteria

currently taking oral contraceptives
English fluency
Ability to provide informed consent

Exclusion Criteria

use of progestin only contraceptive
pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01811225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.